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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001

1. PROTOCOL SUMMARY

1.1. Synopsis

Short Title: A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and
Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

Rationale

A pneumonia of unknown cause detected in Wuhan, China, was first reported in
December 2019. On 08 January 2020, the pathogen causing this outbreak was identified as a
novel coronavirus 2019. The outbreak was declared a Public Health Emergency of
International Concern on 30 January 2020. On 12 February 2020, the virus was officially
named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the WHO
officially named the disease caused by SARS-CoV-2 as coronavirus disease 2019
(COVID-19). On 11 March 2020, the WHO upgraded the status of the COVID-19 outbreak
from epidemic to pandemic, which is now spreading globally at high speed.

There are currently no licensed vaccines to prevent infection with SARS-CoV-2 or
COVID-19. Given the rapid transmission of COVID-19 and incidence of disease in the
United States and elsewhere, the rapid development of an effective vaccine is of utmost
importance.

BioNTech has developed RNA-based vaccine candidates using a platform approach that
enables the rapid development of vaccines against emerging viral diseases, including
SARS-CoV-2. Each vaccine candidate is based on a platform of nucleoside-modified
messenger RNA (modRNA, BNT162b). Each vaccine candidate expresses 1 of 2 antigens:
the SARS-CoV-2 full-length, P2 mutant, prefusion spike glycoprotein (P2 S) (version 9) or a
trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD) (version 5).
The 2 SARS-CoV-2 vaccine candidates that will be tested in this study are therefore:

BNT162b1 (variant RBP020.3): a modRNA encoding the RBD;

BNT162b2 (variant RBP020.2): a modRNA encoding P2 S.

All candidates are formulated in the same lipid nanoparticle (LNP) composition. This study
is intended to investigate the safety, immunogenicity, and efficacy of these prophylactic
BNT162 vaccines against COVID-19.

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